Catalog Number 03P85-50 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
No Information (3190); No Code Available (3191)
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Event Date 12/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
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Event Description
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On (b)(6) 2018, abbott point of care was contacted by a customer regarding i-stat cg4+ cartridges (lot# unk) that yielded suspected discrepant pco2 results during a study of hypothermic babies.There was no patient information available at the time of this report.The customer stated that they are not live for testing at this time and that the results were not used to treat the patient.(b)(6).Test and collection times not available.There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on the limited information available that suggests the product was not performing within the variability of the assay.The investigation is underway.
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Manufacturer Narrative
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Apoc incident #: (b)(4).The investigation was completed on 03/26/2019.A review of the device history record (dhr) confirmed the cartridge lot met finished goods (fg) release criteria.Retained testing met the acceptance criteria outlined in appendix 1 of q04.01.003 rev.Ac (product complaint level 2 and level 3 investigation procedure).No deficiency has been determined for cg4+ lot d18246a.
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Search Alerts/Recalls
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